Composition having tanning and photoprotective activity, and its cosmetic applications

ABSTRACT

An oral or topical composition having tanning and sun-screening activity, and the cosmetic uses thereof, are disclosed. The composition regulates skin pigmentation and includes carotenoids. Said composition essentially contains a component (a) consisting of at least one natural carotenoid having provitamin A activity, and selected from the group which consists of β-carotene and/or α-carotene, and a component (b) corresponding to at least one natural carotenoid having no provitamin A activity, and consisting of lycopene, optionally in combination with a further component (b) selected from the group which consists of zeaxanthine, cryptoxanthine and lutein or a mixture thereof. The ratio of components (a) to lycopene is from 0.95:1 to 1:50.

FIELD OF THE INVENTION

The present invention relates to a composition having tanning and photoprotective activity intended to be administered either by the oral route, or by topical application, as well as to its cosmetic applications.

BACKGROUND

The cutaneous pigmentation of mammals in general, and of man in particular, is based on the biosynthesis of a nitrogenous pigment, melanin, from tyrosine, whose regulation is under the influence of several parameters:

tyrosinase, produced by the pigment cell,

the melanocyte, which under the influence of ultraviolet light catalyses the oxidation of tyrosine to dihydroxyphenylalanine (DOPA), then to dihydroxyindole and finally to melanin,

the melanin can then be subjected to oxidative polymerizations which will accentuate its coloration; this pigment is present in the form of organelles, the melanosomes, in the dendrites of the abovementioned melanocytes and these melanosomes are then transmitted to the keratinocytes, which transport the melanin to the surface of the skin where it is progressively eliminated during natural desquamation.

The melanin formed is composed of two types, (1) eumelanin, which is a black-brown color and is formed by polymerization of oxidation products of dopaquinone and (2) pheomelanin which is a reddish-brown color and is formed by polymerization of sulfur derivatives of dopaquinone; only the first type has a photoprotective effect.

The color of the skin and its intensity thus depend on the melanin content of the keratinocytes, on the type of melanin present in these keratinocytes, on the rate of desquamation and on the thickness of the horny layer which is the layer containing the most pigment.

Essentially for cosmetic reasons, man exposes himself more and more to the sun, in order to have a tanned skin.

However, ultraviolet radiation (UVA and UVB), usually proposed for tanning (sunlamps, for example), have short term as well as long term dangers.

In addition, because of a progressive decrease in the ozone layer, the deleterious effects of ultraviolet solar radiation require the photoprotection of individuals to be increased.

To combat the harmful short-term effects of ultraviolet radiation, namely solar erythema and photosensitization, it is necessary to protect the skin.

However, all of the products for oral administration proposed in the prior art are uniquely centered on the cosmetic effect: obtainment of a "tanned" skin, and comprise the administration of β-carotene at doses clearly higher than those recommended in EEC Directive 90/496, namely 800 μg/day, expressed as vitamin A, or 6 mg of β-carotene/day.

At the doses usually used in these products from the prior art, that is to say of the order of 12 to 30 mg/day, there is accumulation of β-carotene in the keratinocytes, which gives the skin an appearance of "tanning", but does not allow it to have, in addition, active photoprotection by induction of eumelanin, during subsequent exposure to the sun.

Consequently, the Applicant has especially aimed at providing a composition which can be administered by the oral route and which responds better to the needs of practice than the compositions of the prior art, especially in that:

it has a tanning power at daily doses of β-carotene significantly lower than those used earlier to this effect and not exceeding the limits recommended in the abovementioned Directive, and

it has, at the same time, a tanning power and an active photoprotective effect on account of the fact that it especially induces the production of eumelanin.

The present invention relates to a composition for cosmetic purposes, which is a regulator of cutaneous pigmentation and is adapted both to administration by the oral route and to application on the skin, of the type comprising carotenoids, characterized in that it essentially comprises a component (a) formed of at least one carotenoid of natural origin with provitamin A activity selected from the group consisting of β-carotene and α-carotene or a mixture of these, and a component (b), corresponding to at least one carotenoid of natural origin without provitamin A activity, formed by lycopene, optionally associated with another component (b), selected from the group consisting of zeaxanthin, cryptoxanthin and lutein or a mixture of these, the components (a) and the lycopene being in a ratio of between 0.95:1 and 1:50.

Pigmentation regulator, in the sense of the present invention, is understood as meaning an active principle having tanning power, that is to say inducing the endogenous synthesis of melanins.

Surprisingly, at ratios of components (a):lycopene lower than 1, both the composition intended for administration by the oral route and the composition intended to be applied on the skin have a tanning power without exposure to the sun and a photoprotective effect, during subsequent exposure to the sun.

Although the Applicant has found, surprisingly, that the composition intended for administration by the oral route, at daily doses of β-carotene significantly lower than those used previously, has a tanning power and a photoprotective effect when said (a)/lycopene ratio is lower than 1 and preferably of between 0.95:1 and 1:50, there is no limitation of doses for the compositions fit to be applied by the topical route, which comprise the same components (a) and lycopene, in the same ratios as those defined for the compositions administered by the oral route.

SUMMARY OF THE INVENTION

According to an advantageous embodiment of said composition, the component (a) is selected from the group consisting of β-carotene and α-carotene or a mixture of these.

According to another advantageous embodiment of said composition, when it is intended to be administered by the oral route, said composition comprises the component (a) in a dose lower than or equal to 800 μg, expressed as vitamin A, preferably at a dose of 400 μg, expressed as vitamin A. [→a little less than 3 mg of component (a)].

According to another advantageous embodiment of said composition, the component (b) is selected from the group consisting of zeaxanthin, cryptoxanthin, lutein and lycopene or a mixture of these.

According to an advantageous arrangement of this embodiment, the component (b) comprises lycopene at a dose of between 1 and 3 mg.

According to another advantageous embodiment of said composition it additionally comprises vitamins and/or trace elements.

Such compositions have a significant tan-inducing effect (increase in the endogenous synthesis of melanins) without causing carotenoid pigmentation and equally have a photoprotective efficacy (solar erythema).

According to another advantageous embodiment of said composition it additionally comprises at least one appropriate excipient, adapted either to oral administration, or to topical application.

According to another advantageous embodiment of said composition, it is present in the form of soft capsules.

Preferably, to obtain the sought cosmetic effect, such a composition is administered at a rate of 2 units/day.

According to another advantageous embodiment of said composition, it is in the form of cream, of lotion, of liposomes or of gel.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

In addition to the preceding arrangements, the invention also comprises other arrangements, which will emerge from the description which will follow, which refers to examples of carrying out the process which is the subject of the present invention as well as to the attached drawings, in which:

FIG. 1 illustrates the variation of β-carotene in the skin after oral administration of a composition according to the invention (component (a) [β-carotene or B] 2.86 mg and component (b) [lycopene or L]: 3 mg), referred to below as composition B3/L3, compared with a composition comprising 13 mg of component (a) and 2 mg of component (b), referred to as B13/L2; this figure has the time in weeks on the abscissa and the concentration of β-carotene in the skin in μg/ml on the ordinate;

FIGS. 2, 3 and 4 illustrate the evolution of the erythema after oral administration of a composition according to the invention (component (a) [β-carotene or B] 2.86 mg and component (b) [lycopene or L]: 3 mg), referred to below as composition B3/L3 compared with a composition comprising 13 mg of component (a) and 2 mg of component (b), referred to as B13/L2; FIG. 2 comprises the time in weeks on the abscissa and the variation of the oxidized hemoglobin (HbO) with and without erythema, in mg/ml, on the ordinate; FIG. 3 comprises the time in weeks on the abscissa and the variation in hemoglobin (Hb) with and without erythema, in mg/ml, on the ordinate and FIG. 4 comprises the time in weeks on the abscissa and the variation of O₂ with and without erythema, in mg/ml, on the ordinate.

DETAILED DESCRIPTION

It must be well understood, however, that these examples are given uniquely by way of illustration of the subject of the invention, of which they are not in any way a limitation.

EXAMPLE 1 Preparation of a Composition for Oral Administration According to the Invention

    ______________________________________                                         Soft capsules containing:                                                                              B3/L3                                                  ______________________________________                                         Excipients:                                                                    Hydrogenated soybean oil                                                                               40 mg                                                  Wheat oil               95 mg                                                  Soybean lecithin        20 mg                                                  Vitamins:                                                                      Natural tocopherols      5 mg                                                  Ascorbic acid           30 mg                                                  Component (a):                                                                 20% betatene            15 mg.sup.1                                            Component (b):                                                                 5% lycopene             60 mg.sup.2                                            ______________________________________                                         A suspension of 20% betatene comprises 200 mg/g                                of carotenoids divided as follows:                                                    β-carotene                                                                        190.5                                                                  α-carotene                                                                       6                                                                      zeaxanthin                                                                             1.2                                                                    cryptoxanthin                                                                          1.4                                                                    lutein  0.9                                                             ______________________________________                                          .sup.1 Corresponding to 2.86 mg of component (a) and .sup.2 corresponding      to 3 mg of lycopene.                                                     

EXAMPLE 2 Study of the Tanning Effect and of the Photoprotective Effect of the Composition According to Example 1 (Referred to as B3/L3) Comparison with a Composition Comprising 13 mg of Carotenoids Having Provitamin A Activity and 2 mg of Lycopene (Referred to as B13/L2)

The study is a single-center, double-blind, randomized 8-week study of a B3/L3 composition according to the invention according to Example 1 and of a B13/L2 composition comprising 13 mg of carotenoids having provitamin A β-carotene activity, including a total of 20 subjects. This study was carried out in Germany, in winter.

DETAILS OF THE STUDY

The subjects are selected after a medical examination intended to verify their general good state of health.

Regular visits are necessary to verify tolerance and to carry out the evaluation of:

exposure to UV

chromametric measurements of the value of b (yellow), L (luminescence) and a (red)

direct determination by multiple reflection spectrometry of: hemoglobin, oxidized hemoglobin, oxygen, melanins and β-carotene.

The efficacy is determined by a significant improvement in these parameters by comparing them with the results obtained on the day of randomization, before taking the composition.

The dose-response relationship is evaluated by the determination of the number of responders in each group.

    ______________________________________                                         DESCRIPTION OF THE STUDY                                                       ______________________________________                                         Day          D-28    D0      D7    D14   D28                                   ______________________________________                                         Visit number V1      V2V3    V4V5  V6V7  V8V9                                  Clinical examination                                                                        *       *       *     *     *                                     Exposure to UV                                                                              *       *       *     *     *                                     Chromametry  *       *       *     *     *                                     Spectrometry *       *       *     *     *                                     Agreed consent                                                                              *                                                                 Randomization                                                                               *                                                                 Supply of the nutritional                                                                   *       *       *     *     *                                     composition to be tested                                                       Undesirable events                                                                          *       *       *     *     *                                     ______________________________________                                         The composition B13/L2 consists of soft capsules                               having the following formula:                                                                     B13/L2                                                      ______________________________________                                         Hydrogenated soybean oil                                                                          40 mg                                                       Wheat oil          95 mg                                                       Soybean lecithin   20 mg                                                       Natural tocopherols                                                                                5 mg                                                       Ascorbic acid      30 mg                                                       20% betatene       .sup. 65 mg.sup.1                                           5% lycopene        .sup. 40 mg.sup.2                                           ______________________________________                                          .sup.1 Corresponding to 12.42 mg of carotenoids having provitamin A            activity and                                                                   .sup.2 corresponding to 2 mg of lycopene.                                

The daily treatment is one of the following:

2 capsules of B13/L2 or

2 capsules of B3/L3,

at a rate of 2 capsules a day between 7 and 9 a.m. with breakfast.

Results:

The results obtained are illustrated in Tables I to V below and in FIGS. 1 to 4 and show that the decrease in β-carotene in a composition according to the invention, with respect to the compositions of the prior art, gives a significant decrease in the erythema obtained after UV irradiation (Table III and FIG. 2: evaluation of the erythema by measurement of variations of HbO, Table IV and FIG. 3: evaluation of the erythema by measurement of variations of Hb and Table V and FIG. 4: evaluation of the erythema by measurement of variations of O₂), which, surprisingly, it was not possible to obtain with a high concentration of β-carotene; in addition, Tables I and II show that a composition according to the invention effectively gives a significant increase in tanning by endogenous synthesis of melanins without carotenoid pigmentation.

                                      TABLE I                                      __________________________________________________________________________     MELANIN (MEAN FOREHEAD, INTERNAL AND EXTERNAL                                  FACE OF THE HAND, INTERNAL FACE                                                FOREARM AND BACK) MG/ML                                                        BEFORE    AFTER 4 WEEKS                                                                           AFTER 5 WEEKS                                                                           AFTER 6 WEEKS                                                                           AFTER 8 WEEKS                             __________________________________________________________________________     B13/L2                                                                         Subject 1                                                                            0.57                                                                               0.59     0.66     0.60     0.61                                      Subject 5                                                                            0.56                                                                               0.61     0.61     0.60     0.63                                      Subject 6                                                                            0.59                                                                               0.64     0.67     0.64     0.64                                      Subject 8                                                                            0.62                                                                               0.66     0.66     0.65     0.65                                      Subject 10                                                                          0.62 0.65     0.66     0.69     0.63                                      Subject 11                                                                          0.65 0.71     0.70     0.72     0.68                                      Subject 12                                                                          0.64 0.71     0.69     0.74     0.70                                      Subject 15                                                                          0.62 0.65     0.63     0.68     0.65                                      Subject 16                                                                          0.58 0.63     0.62     0.63     0.60                                      Subject 19                                                                          0.57 0.63     0.61     0.63     0.64                                      Mean      0.650    0.65     0.66     0.64                                      SD        0.04.03  0.03     0.05     0.03                                      B3/L3                                                                          Subject 2                                                                            0.58                                                                               0.63     0.62     0.64     0.61                                      Subject 3                                                                            0.68                                                                               0.66     0.66     0.65     0.64                                      Subject 4                                                                            0.58                                                                               0.63     0.63     0.62     0.63                                      Subject 7                                                                            0.65                                                                               0.70     0.70     0.65     0.64                                      Subject 9                                                                            0.63                                                                               0.67     0.66     0.70     0.67                                      Subject 13                                                                          0.62 0.70     0.65     0.70     ND                                        Subject 14                                                                          0.62 0.64     0.63     0.66     0.67                                      Subject 17                                                                          0.63 0.67     0.67     0.68     0.68                                      Subject 18                                                                          0.61 0.67     0.64     0.66     0.64                                      Subject 20                                                                          0.59 0.58     0.61     0.59     0.61                                      Mean      0.662    0.65     0.66     0.64                                      SD        0.04.03  0.03     0.03     0.03                                      __________________________________________________________________________

                                      TABLE II                                     __________________________________________________________________________                 CONCENTRATIONS OF BETA-CAROTENE IN THE SKIN                                         AFTER AFTER                                                                               AFTER AFTER                                                    BEFORE                                                                              4 WEEKS                                                                              5 WEEKS                                                                             6 WEEKS                                                                              8 WEEKS                                      __________________________________________________________________________     B13/L2                                                                         Back with erythema                                                                          184.76                                                                             238.08                                                                               208.97                                                                              224.24                                                                               296.57                                       Back without erythema                                                                      73.21                                                                               161.26                                                                               116.28                                                                              101.51                                                                               148.13                                       Internal face of the                                                                       55.59                                                                               85.42 73.28                                                                               73.49 84.4                                         forearm                                                                        External face of the hand                                                                   76.61                                                                              139.54                                                                               70.91                                                                               110.23                                                                               120.41                                       Internal face of the hand                                                                   348.1                                                                              329.27                                                                               240.24                                                                              346.42                                                                               437.09                                       Forehead    237.91                                                                              314.92                                                                               438.57                                                                              329.26                                                                               447.82                                       Mean        162.70                                                                              211.42                                                                               191.38                                                                              197.53                                                                               255.74                                       B3/L3                                                                          Back with erythema                                                                         266.2                                                                               222.96                                                                               192.99                                                                              228.88                                                                               285.8                                        Back without erythema                                                                      126.58                                                                              91.07 92.23                                                                               125.68                                                                               106.15                                       Internal face of the                                                                       52.5 49.5  17.76                                                                               40.95 23.8                                         forearm                                                                        External face of the hand                                                                  70.1 112.54                                                                               53.24                                                                               108.68                                                                               84.88                                        Internal face of the hand                                                                  223.61                                                                              261.66                                                                               245.78                                                                              257.25                                                                               126.75                                       Forearm     239.5                                                                               177.61                                                                               260.3                                                                               180.91                                                                               195.16                                       Mean        163.08                                                                              152.56                                                                               143.72                                                                              157.06                                                                               137.09                                       __________________________________________________________________________

                                      TABLE III                                    __________________________________________________________________________     HbO (BACK WITH ERYTHEMA) - HbO (BACK WITHOUT ERYTHEMA)                                   AFTER 4                                                                             AFTER 5                                                                             AFTER 6                                                                             AFTER 8                                                                             MEAN MEAN                                        BEFORE    WEEKS                                                                               WEEKS                                                                               WEEKS                                                                               WEEKS                                                                               (n = 5)                                                                             (n = 4)                                     __________________________________________________________________________     B13/L2                                                                         Subject 1                                                                            0.93                                                                               0.66 1.21 -0.23                                                                               0.14 0.54 0.45                                        Subject 5                                                                            1.41                                                                               2.12 0.38 0.1  1.46 1.09 0.99                                        Subject 6                                                                            -0.14                                                                              0.28 1.03 0.44 1.03 0.53 0.70                                        Subject 8                                                                            0.34                                                                               0.55 0.04 0.91 0.16 0.40 0.42                                        Subject 10                                                                          0.69 1.26 1.14 1.32 0.89 1.06 1.15                                        Subject 11                                                                          0.8  0.68 0.72 0.83 1.47 0.9  0.93                                        Subject 12                                                                          1.68 -0.01                                                                               -0.29                                                                               0.98 0.59 0.59 0.32                                        Subject 15                                                                          0.34 0.03 1.3  0.63 0.42 0.54 0.60                                        Subject 16                                                                          0.04 0.26 0.12 0.31 -0.1 0.13 0.15                                        Subject 19                                                                          -0.09                                                                               1.09 0.3  1.27 1.16 0.75 0.96                                        Mean      0.69 0.60 0.66 0.72 0.65 0.67                                        SD   0.62 0.65 0.56 0.50 0.56                                                  B3/L3                                                                          Subject 2                                                                           0.25 0.58 -0.18                                                                               1.28 1.17 0.62 0.71                                        Subject 3                                                                           0.08 0.19 1.09 0.04 0.31 0.34 0.41                                        Subject 4                                                                           0.52 -0.08                                                                               0.42 0.54 0.75 0.43 0.41                                        Subject 7                                                                           0.48 0.35 0.82 1.19 0.41 0.65 0.69                                        Subject 9                                                                           1.55 0.21 0.51 -0.06                                                                               2.5  0.94 0.79                                        Subject 13                                                                          0.61 -0.03                                                                               0.04 0.02 ND   0.16 0.01                                        Subject 14                                                                          1.24 -0.11                                                                               -0.13                                                                               -0.11                                                                               0.08 0.19 -0.07                                       Subject 17                                                                          1.18 1.81 0.1  0.54 1.02 0.93 0.87                                        Subject 18                                                                          1.32 1.6  1.57 0.81 1.86 1.43 1.46                                        Subject 20                                                                          0.41 0.98 1    0.43 0.55 0.67 0.74                                        Mean      0.556                                                                               0.52 0.47 0.96 0.64 0.60                                        SD        0.67.69                                                                             0.58 0.51 0.81                                                  __________________________________________________________________________

                                      TABLE IV                                     __________________________________________________________________________     Hb (BACK WITH ERYTHEMA) - Hb (BACK WITHOUT ERYTHEMA)                                     AFTER 4                                                                             AFTER 5                                                                             AFTER 6                                                                             AFTER 8                                                                             MEAN MEAN                                        BEFORE    WEEKS                                                                               WEEKS                                                                               WEEKS                                                                               WEEKS                                                                               (n = 5)                                                                             (n = 4)                                     __________________________________________________________________________     B13/L2                                                                         Subject 1                                                                            1.01                                                                               0.57 1.21 -0.23                                                                               0.14 0.54 0.42                                        Subject 5                                                                            1.65                                                                               2.4  0.37 -0.07                                                                               0.87 1.21 1.11                                        Subject 6                                                                            -0.37                                                                              -0.31                                                                               0.65 0.17 0.87 0.20 0.35                                        Subject 8                                                                            0.37                                                                               0.64 -0.21                                                                               0.86 0.32 0.40 0.40                                        Subject 10                                                                          0.97 1.1  1.16 1.59 0.45 1.05 1.08                                        Subject 11                                                                          0.89 0.67 0.49 0.81 1.39 0.85 0.84                                        Subject 12                                                                          1.26 0.04 -0.75                                                                               1    0.78 0.47 0.27                                        Subject 15                                                                          0.23 -0.08                                                                               1.72 0.56 0.51 0.59 0.68                                        Subject 16                                                                          -0.23                                                                               0.17 -0.23                                                                               -0.17                                                                               -0.49                                                                               -0.19                                                                               -0.18                                       Subject 19                                                                          -0.55                                                                               1.2  -0.37                                                                               1.3  0.97 0.51 0.78                                        Mean  0.523                                                                              0.64 0.404                                                                               0.582                                                                               0.666                                                                               0.56 0.57                                        SD      0.73                                                                             0.79 0.80 0.64 0.63                                                  B3/L3                                                                          Subject 2                                                                           -0.07                                                                               0.61 -0.37                                                                               0.43 0.87 0.29 0.39                                        Subject 3                                                                           -0.34                                                                               0.08 1.32 -0.02                                                                               0.2  0.25 0.40                                        Subject 4                                                                           0.61 -0.84                                                                               -0.37                                                                               0.56 0.78 0.15 0.03                                        Subject 7                                                                           0.61 0.56 0.64 1.25 0.82 0.78 0.82                                        Subject 9                                                                           1.61 9.7  1.05 -0.18                                                                               2.5  2.94 not taken                                                                      into                                                                           account                                     Subject 13                                                                          0.43 0.11 0.04 -0.02                                                                               ND   0.14 0.04                                        Subject 14                                                                          0.83 -1.26                                                                               -1.29                                                                               -1.23                                                                               0.45 -0.3 -0.58                                       Subject 17                                                                          0.78 1.8  -0.18                                                                               0.55 0.71 0.73 0.72                                        Subject 18                                                                          1.44 1.46 1.24 0.98 2.05 1.43 1.43                                        Subject 20                                                                          0.46 0.12 0.67 0.33 -0.08                                                                               0.3  0.26                                        Mean      0.53                                                                           0.29 0.19 0.43 0.72 0.42 0.39                                        SD        0.982                                                                               0.85 0.48 0.84                                                  __________________________________________________________________________

                                      TABLE V                                      __________________________________________________________________________     Oxygen (BACK WITH ERYTHEMA) - Oxygen (BACK WITHOUT ERYTHEMA)                             AFTER 4                                                                             AFTER 5                                                                             AFTER 6                                                                             AFTER 8                                                                             MEAN MEAN                                        BEFORE    WEEKS                                                                               WEEKS                                                                               WEEKS                                                                               WEEKS                                                                               (n = 5)                                                                             (n = 4)                                     __________________________________________________________________________     B13/L2                                                                         Subject 1                                                                            52  34.2 42.7 27.4 22.8 35.82                                                                               31.78                                       Subject 5                                                                            49.5                                                                               40.9 32   12.9 39.4 34.94                                                                               31.30                                       Subject 6                                                                            10.1                                                                               41   49.6 45   34.9 36.12                                                                               42.63                                       Subject 8                                                                           24.5 22.1 15.2 25   6.6  18.68                                                                               17.23                                       Subject 10                                                                          7.9  49.4 46.6 27.7 32.5 32.82                                                                               39.05                                       Subject 11                                                                          31.1 50   63.4 ND   40.5 46.25                                                                               51.3                                        Subject 12                                                                          66.2 302  -5.3 44.2 31.2 not taken                                                                           not taken                                                                 into into                                                                      account                                                                             account                                     Subject 15                                                                          46.8 21   29.3 64.5 24.2 37.16                                                                               34.75                                       Subject 16                                                                          28.1 15.4 39.8 38.5 8.9  26.14                                                                               25.9                                        Subject 19                                                                          17.1 16.3 34.7 36.1 31.5 27.14                                                                               25.65                                       Mean      32.268                                                                              39.26                                                                               34.64                                                                               26.8 29.15                                                                               33.28                                       SD        16.33.13                                                                            17.67                                                                               19.81                                                                               12.34                                                 B3/L3                                                                          Subject 2                                                                           57.9 32   -4.4 38.4 66.3 38.04                                                                               33.08                                       Subject 3                                                                           33.8 35.9 32.7 6.1  29.3 27.56                                                                               26.00                                       Subject 4                                                                           42.8 62.7 32.4 45   38.1 44.20                                                                               44.55                                       Subject 7                                                                           15.1 7.5  42.4 46.2 6.3  23.50                                                                               25.60                                       Subject 9                                                                           41.7 29.7 -2.7 -4.4 38.2 20.50                                                                               15.2                                        Subject 13                                                                          44.6 -13.5                                                                               3.9  -4.4 ND   7.65 -4.67                                       Subject 14                                                                          51.1 32.5 35.9 -9   41.2 30.34                                                                               25.15                                       Subject 17                                                                          56.4 52.4 15.9 24.9 28   35.52                                                                               30.3                                        Subject 18                                                                          57.1 32.1 49.6 36.2 44.2 43.84                                                                               40.53                                       Subject 20                                                                          12.9 32.1 49.6 36.2 45   35.76                                                                               41.48                                       Mean   41.34                                                                             31.25                                                                               24.85                                                                               21.59                                                                               37.40                                                                               30.69                                                                               27.72                                       SD   16.37                                                                               21.42                                                                               20.05                                                                               21.51                                                                               16.11                                                 __________________________________________________________________________

EXAMPLE 3 Preparation of a Composition for Topical Administration According to the Invention

    ______________________________________                                                               B3/L3                                                    ______________________________________                                         Excipients:                                                                    Soybean lecithin        80 mg                                                  Hydrogenated soybean oil                                                                               40 mg                                                  Ceramides               20 mg                                                  Vitamins:                                                                      Natural tocopherols     5 mg                                                   Ascorbic acid           30 mg                                                  Component (a):                                                                 20% betatene                                                                   Component (b):          15 mg.sup.1                                            5% lycopene             60 mg.sup.2                                            ______________________________________                                          .sup.1 Corresponding to 2.86 mg of component (a) and                           .sup.2 corresponding to 3 mg of lycopene.                                

As emerges from the text hereinabove, the invention is not limited by any means to the embodiments and modes of application which are described more explicitly; on the contrary, it embraces all the variants which can come to the mind of a person skilled in the art, without departing from the scope or the range of the present invention. 

What is claimed is:
 1. A topical or oral composition comprising a carotenoid having provitamin A activity selected from the group consisting of β-carotene, α-carotene and mixtures thereof; in admixture with lycopene, wherein the ratio of carotenoid having provitamin A activity to lycopene is from 0.95:1 to 1:50.
 2. The composition of claim 1 further comprising a carotenoid without provitamin A activity selected from the group consisting of zeaxanthin, cryptoxanthin, lutein, and mixtures thereof.
 3. The composition of claim 1 wherein the amount of lycopene is between about 1 and about 3 mg.
 4. The composition as claimed in any one of claims 1-3, further comprising vitamins and/or trace elements.
 5. The composition as claimed in any one of claims 1-3, wherein said carotenoid having provitamin A activity is present in an amount lower than or equal to 800 μg expressed as vitamin A.
 6. The composition of claim 5, wherein said carotenoid having provitamin A activity is present in an amount lower than or equal to 400 μg expressed as vitamin A.
 7. The composition of claim 5, further comprising at least one excipient appropriate for oral administration of the composition.
 8. The composition of claim 7, wherein said excipient provides for formulation as a soft capsule.
 9. The composition as claimed in any one of claims 1-3, further comprising at least one excipient appropriate for topical administration of the composition.
 10. The composition of claim 9, wherein said excipient provides for formulation as a cream, a lotion, a liposome or a gel.
 11. A method of treatment for tanning skin and providing photoprotection comprising orally administering a daily dose of an effective amount of the composition as claimed in claim
 5. 12. A method of treatment for tanning skin and providing photoprotection comprising orally administering a daily dose of an effective amount of the composition as claimed in claim
 7. 13. A method of treatment for tanning skin and providing photoprotection comprising topically administering an effective amount of the composition as claimed in claim
 9. 14. A method of treatment for tanning skin and providing photoprotection comprising topically administering an effective amount of the composition as claimed in claim
 10. 15. A method of treatment for tanning skin and providing photoprotection comprising orally administering a daily dose of an effective amount of the composition as claimed in claim
 8. 16. The composition of claim 5, wherein said carotenoid having provitamin A activity is present in an amount of 400 μg expressed as vitamin A. 